BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2060735 · Received April 8, 2011

    Report

    Report Number
    2531779-2011-02381
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVAL HAS NOT YET BEEN COMPLETED. WHEN EVAL IS COMPLETE THE RESULTS WILL BE PROVIDE IN THE SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE KEYPAD RUBBER WAS TORN NEAR THE OK BUTTON, WHICH WAS FIRST DISCOVERED SEVERAL WEEKS BEFORE CALLING ANIMAS AND GETTING WORSE WITH TIME. HE STATES THE AUDIO BOLUS AND CONTRAST BUTTONS HAVE ONLY INTERMITTENTLY ACTIVATED PUMP FUNCTIONS WHEN PRESSED SINCE NOTICING THE TEAR ON THE KEYPAD. THE PT DENIES THAT THE PUMP WAS EXPOSED TO WATER OR CLEANING PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR